A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Follicular Lymphoma

Concentrations of odronextamab in serum

Part 1

Time frame: Up to 30 months

Incidence of Anti-Drug Antibodies (ADAs) to odronextamab over the study duration

Part 1

Time frame: Up to 30 months

Magnitude of ADAs to odronextamab over the study duration

Part 1

Time frame: Up to 30 months

Objective response as assessed by the investigator

Part 1

Time frame: Up to 30 months

Progression-Free Survival (PFS) as assessed by independent central review

Part 2

Time frame: Up to 5 years

Event-Free Survival (EFS) as assessed by independent central review

Part 2

Time frame: Up to 5 years

Overall Survival (OS)

Part 2

Time frame: Up to 5 years

Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

CR30 as assessed by local investigator

Part 2

Time frame: Up to 30 months

PFS as assessed by the local investigator

Part 2

Time frame: Up to 5 years

EFS as assessed by the local investigator

Part 2

Time frame: Up to 5 years

Objective response assessed by local investigator

Part 2

Time frame: Up to 30 months

Objective response assessed by independent central review

Part 2

Time frame: Up to 30 months

Duration Of Response (DOR) assessed by independent central review

Part 2

Time frame: Up to 5 years

DOR assessed by local investigator

Part 2

Time frame: Up to 5 years

Time To Next anti-lymphoma Treatment (TTNT)

Part 2

Time frame: Up to 5 years

Incidence of TEAEs

Part 2

Time frame: Up to 2 years

Severity of TEAEs

Part 2

Time frame: Up to 2 years

Odronextamab concentrations in serum during the induction period

Part 2

Time frame: Up to 30 months

Odronextamab concentrations in serum during the maintenance period

Part 2

Time frame: Up to 30 months

Incidence of ADAs to odronextamab over the study duration

Part 2

Time frame: Up to 30 months

Magnitude of ADAs to odronextamab over the study duration

Part 2

Time frame: Up to 30 months

Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)

Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

Time frame: Up to 5 years

Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)

Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

Time frame: Up to 5 years

Change in Patient Global Impression of Severity (PGIS)

Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).

Time frame: Up to 5 years

Change in Patient Global Impression of Change (PGIC)

Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.

Time frame: Up to 5 years

Change in score of the GP5 item in the participant population

Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

Time frame: Up to 5 years